BONIVA(R) F. C. Tablets (150 mg)
Safety Data Sheet
SECTION 1: Identification of the substance/mixture and of the
company/undertaking
1.1. Product identifier
Product name
BONIVA(R) F. C. Tablets (150 mg)
Product code
SAP-10069261
Synonyms
- BONVIVA Film Coated Tablets
- BONVIVA F.C. Tablets
1.2. Relevant identified uses of the substance or mixture and uses advised against
Use
- pharmaceutical active substance (postmenopausal osteoporosis)
*1
1.3. Details of the supplier of the safety data sheet
Company information
Enquiries:
Genentech, Inc.
1 DNA Way
South San Francisco
USA-CA 94080
United States of America
Local representation:
Phone
001-(650) 225-1000
E-Mail
[email protected]
US Chemtrec phone:
(800)-424-9300
1.4. Emergency telephone number
Emergency telephone number
US Chemtrec phone: (800)-424-9300
*1
Ibandronate
referring to:
Date: 2.7.15/LS (SEISMO)
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BONIVA(R) F. C. Tablets (150 mg)
SECTION 2: Hazards identification
Classification of the substance or mixture / Label elements
GHS Classification
Health Hazards:
3.9Specific target organ toxicity - Repeated exposure (Category
2)
H373 May cause damage to organs through prolonged or
repeated exposure.
Signalword: Warning
Label:
Precautionary statements:
- P273 Avoid release to the environment.
- P314 Get medical advice/attention if you feel unwell.
Other hazards
Note
- no information available
SECTION 3: Composition/information on ingredients
Characterization
Ibandronate and other inactive ingredients
Ingredients
Concentration
GHS-Classification
(pure ingredient)
Ibandronate
138926-19-9
36.3 %
-
Microcrystalline cellulose
9004-34-6
12.9 %
Stearic acid purified fine grade
57-11-4
2%
Combustible dust (No category), USH003
Acute toxicity (Category 4), H302
Skin corrosion/irritation (Category 1B), H314
Specific target organ toxicity - Repeated
exposure (Category 2), H373
Silicon dioxide colloidal (Aerosil 200, silica)
1%
7631-86-9
For the full text of the H-phrases mentioned in this Section, see Section 16.
Date: 2.7.15/LS (SEISMO)
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BONIVA(R) F. C. Tablets (150 mg)
SECTION 4: First aid measures
4.1. Description of first aid measures
Eye contact
- rinse immediately with tap water for 10 minutes - open eyelids
forcibly
- consult a physician
Skin contact
- remove immediately contaminated clothes, wash affected skin
with water and soap - do not use any solvents
Inhalation
- remove the casualty to fresh air and keep him/her calm
- in the event of symptoms get medical treatment
4.2. Most important symptoms and effects, both acute and delayed
Note
- no information available
4.3. Indication of any immediate medical attention and special treatment needed
Note to physician
- treat symptomatically
SECTION 5: Firefighting measures
5.1. Extinguishing media
Suitable extinguishing media
Flash point (liquid)
- adapt extinguishing media to surrounding fire conditions
not applicable
5.2. Special hazards arising from the substance or mixture
Specific hazards
- formation of toxic and corrosive combustion gases (nitrous oxides,
phosphorous oxides) possible
- consider dust explosion hazard
- consider danger for the environment: dike spilled liquid
5.3. Advice for firefighters
Protection of fire-fighters
- precipitate gases/vapours/mists with water spray
Special method of fire-fighting
- for reasons of environmental protection hold the extinguishing
agent back
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
Personal precautions
Date: 2.7.15/LS (SEISMO)
- ensure adequate ventilation
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BONIVA(R) F. C. Tablets (150 mg)
6.2. Environmental precautions
Environmental protection
- do not allow to enter drains or waterways
- if the substance reaches waters or the sewer system, inform the
competent authority
6.3. Methods and material for containment and cleaning up
Methods for cleaning up
- collect solids (avoid dust formation) and hand over to waste
removal
SECTION 7: Handling and storage
7.1. Precautions for safe handling
Technical measures
- avoid formation and deposition of dust
- provide suitable exhaust ventilation at the processing machines
Suitable materials
- glass, enamel, polyethylene, stainless steel
7.2. Conditions for safe storage, including any incompatibilities
Storage conditions
- protected from heat and light
- protected from humidity
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
Threshold value (USA) air
Threshold value (Roche) air
-
ACGIH-TLV: 10 mg/m3
OSHA-PEL: 15 mg/m3 (total dust)
OSHA-PEL: 5 mg/m3 (respirable fraction)
NIOSH-REL: 10 mg/m3 (total dust)
NIOSH-REL: 5 mg/m3 (respirable fraction)
ACGIH-TLV: 3 mg/m3 (respirable fraction)
ACGIH-TLV: 10 mg/m3 (inhalable fraction)
OSHA-PEL: 6 mg/m3
NIOSH-REL: 6 mg/m3
*2
*2
*2
*2
*2
*3
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*3
*3
- IOEL (Internal Occupational Exposure Limit): 0.002 mg/m3
*1
8.2. Exposure controls
Respiratory protection
Date: 2.7.15/LS (SEISMO)
- Respiratory protection is recommended as a precaution to
minimize exposure. Effective engineering controls are considered
to be the primary means to control worker exposure. Respiratory
protection should not substitute for feasible engineering controls.
- in case of open handling or accidental release:
particle mask or respirator with independent air supply
- respiratory protection not necessary during normal operations
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BONIVA(R) F. C. Tablets (150 mg)
Hand protection
- protective gloves (eg made of neoprene, nitrile or butyl rubber)
Eye protection
- safety glasses
*1
*2
*3
referring to:
referring to:
referring to:
Ibandronate
Microcrystalline cellulose
Silicon dioxide colloidal (Aerosil 200, silica)
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Color
white to cream-colored
Form
oblong biconvex
tablets
Odor
odourless
Solubility
103’100 mg/l, water (20 °C)
*1
Melting temperature
165 to 175 °C (with decomposition)
*1
9.2. Other information
Note
*1
- no information available
referring to:
Ibandronate
SECTION 10: Stability and reactivity
10.1. Reactivity
Note
- no information available
10.2. Chemical stability
Stability
- stable under the conditions mentioned in chapter 7
10.3. Possibility of hazardous reactions
Note
- no information available
10.4. Conditions to avoid
Note
- no information available
10.5. Incompatible materials
Note
Date: 2.7.15/LS (SEISMO)
- no information available
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BONIVA(R) F. C. Tablets (150 mg)
10.6. Hazardous decomposition products
Note
- no information available
SECTION 11: Toxicological information
11.1. Information on toxicological effects
Acute toxicity
- LD50
Local effects
- skin, eyes, mucous membranes: corrosive
*1
Sensitization
- non-sensitizing (guinea pig)
*1
Mutagenicity
- not mutagenic (various in vivo and in vitro test systems)
*1
Carcinogenicity
- not carcinogenic (several species)
*1
Reproductive toxicity
- not teratogenic, not embryotoxic (several species)
- does not lower parental fertility (several species)
*1
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Note
- inhibits mechanisms reducing bone mass by long-term binding to
bone tissue
- high doses cause: liver damages, kidney damages
- decrease in serum calcium level possible
- dosage (oral): 2.5 to 50 mg/d
- dosage (i.v.): 0.5 mg/3 months to 2.5 mg/day
Potential Health Effects
811
mg/kg
(oral, rat)
*1
*1
*3
referring to:
referring to:
*1
*1
*1
*1
- Exposure: Ingestion
- Carcinogenicity: formulation not listed by NTP, IARC or OSHA
- Carcinogenicity: IARC Gr3 not classifiable
Additional Health Information
*1
*3
- Conditions Aggravated: Hypersensitivity to this material and other
materials in its chemical class. Uncorrected hypocalcemia.
Severe renal impairment.
Ibandronate
Silicon dioxide colloidal (Aerosil 200, silica)
SECTION 12: Ecological information
12.1. Toxicity
Ecotoxicity
Date: 2.7.15/LS (SEISMO)
- strongly toxic for algae (Selenastrum capricornutum)
EbC50 (72 h) 1.4 mg/l
ErC50 (72 h) 4.7 mg/l
NOEC (72 h) 0.22 mg/l
(OECD No. 201)
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19.6.14
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BONIVA(R) F. C. Tablets (150 mg)
- highly toxic for algae (Scenedesmus (=Desmodesmus)
subspicatus)
EbC50 (72 h) 0.218 mg/l (nominal concentration)
ErC50 (72 h) 0.390 mg/l (nominal concentration)
NOEC (72 h) < 0.1 mg/l (nominal concentration)
(OECD No. 201)
*1
- barely toxic for planktonic crustaceans (Daphnia magna)
NOEC (48 h) 100 mg/l
EC50 (48 h) > 180 mg/l
(OECD No. 202)
*1
- no adverse influence on substrate biodegradation (activated
sludge)
concentration (28 d) 41.5 mg/l
(OECD No. 301B, Modified Sturm Test)
*1
- barely inhibitory on aerobic bacterial reproduction (activated sludge)
NOEC (5 h) 1300 mg/l
(growth test)
*1
- barely toxic for fish (carp)
LC50 (96 h) 200 mg/l
LC0 (96 h) 86 mg/l
(OECD No. 203)
*1
- highly toxic for algae (Scenedesmus (=Desmodesmus)
subspicatus)
EC50 (14 d) 0.5 mg/l (nominal concentration)
NOEC (14 d) 0.1 mg/l (nominal concentration)
(OECD No. 201)
*1
- no adverse influence on substrate biodegradation
concentration (28 d) 100 mg/l
(Manometric Respirometry Test, OECD No. 301 F)
*1
12.2. Persistence and degradability
Ready biodegradability
Inherent biodegradability
Abiotic degradation
- not readily biodegradable
≤ 3 %, 28 d
(CO2 Evolution Test, Modified Sturm Test, OECD No. 301B)
- not readily biodegradable
0 %, 28 d
(Manometric Respirometry Test, OECD No. 301 F)
- not inherently biodegradable
< 10 %, 1 d
< 10 %, 15 d
< 10 %, 28 d
(Zahn-Wellens test, OECD No. 302 B)
- not inherently biodegradable
< 10 %, 28 d
(Zahn-Wellens test, OECD No. 302 B)
- stable in water, no photodegradation 200 mg/l, water
< 2 %, 14 d, ~ 22 °C, under illumination
*1
*1
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12.3. Bioaccumulative potential
Note
Date: 2.7.15/LS (SEISMO)
- no information available
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BONIVA(R) F. C. Tablets (150 mg)
12.4. Mobility in soil
Note
- no information available
Mobility
- no significant adsorption (, 28 d, ~22 °C)
Kd = 1210 l/kg (activated sludge)
(Adsorption to activated sludge in biodegradability test)
*1
12.5. Results of PBT and vPvB assessment
Note
- no information available
12.6. Other adverse effects
Note
- no information available
Note
- after the regular 28 days in the Zahn-Wellens test, without
significant degradation and still 400 mg DOC/l, 200 mg DOC/l
benzoate was added as a well degradable substrate; after 5 days,
only 150 mg DOC/l was left, showing some cometabolic
degradation
*1
*1
referring to:
Ibandronate
SECTION 13: Disposal considerations
13.1. Waste treatment methods
Waste from residues
-
return to supplier or hand over to authorized disposal company
observe local/national regulations regarding waste disposal
incinerate in qualified installation with flue gas scrubbing
DO NOT FLUSH unused medications or POUR them down a sink
or drain. If available in your area, use takeback programs run by
household hazardous waste collection programs or community
pharmacies to dispose of unused and expired medicines. If you
don’t have access to a takeback program, dispose of these
medicines in the household trash by removing them from their
original containers and mixing them with an undesirable
substance, such as used coffee grounds or kitty litter.
SECTION 14: Transport information
IATA
IMDG
Class
UN/ID
9
3077
Class
UN
9
3077
Date: 2.7.15/LS (SEISMO)
PG
III
PG
III
EmS
F-A S-F
PI
Label
Mark
956/956
9
EHS
PI
Label
Mark
P002/IBC08
9
marine pollutant
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BONIVA(R) F. C. Tablets (150 mg)
RID/ADR
DOT
Class
UN
9
3077
Class
UN/ID
9
3077
PG
III
PG
Haz.no
PI
Label
Mark
Classif.
code
90
P002/IBC08
9
EHS
M7
RQ
Label
Haz.no
PI
III
9
DOT Remark:
- NON-REGULATED IN NON-BULK PACKAGINGS
TRANSPORTED BY MOTOR VEHICLES, RAIL CARS OR
AIRCRAFT (49CFR 171.4(c)).
Proper shipping name
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
Technical name
Ibandronate
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
TSCA Status
- FDA Exemption - not on inventory
Reporting Requirements
- The United States Environmental Protection Agency (USEPA) has
not established a Reportable Quantity (RQ) for releases of this
material.
- In New Jersey, report all releases which enter a waterway or into
soil, or which are likely to endanger the public health, harm the
environment or cause a complaint to the NJDEPE Hotline
(1-609-292-5560) and to local officials.
- State and local regulations vary and may impose additional
reporting requirements.
SECTION 16: Other information
Safety-lab number
- BS-9383
- BS-9382
- BS-9301
*1
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Full text of H-Statements referred to under section 3
H302
Harmful if swallowed.
H314
Causes severe skin burns and eye damage.
H373
May cause damage to organs through prolonged or repeated
exposure.
USH003 May form combustible dust concentrations in the air
Date: 2.7.15/LS (SEISMO)
Replacing edition of:
19.6.14
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BONIVA(R) F. C. Tablets (150 mg)
Note
- Please note this Safety Data Sheet for the bulk product does not
apply for the finished, packaged medicinal product intended for
the final user.
Edition documentation
- changes from previous version in sections 2, 3, 13, 16
*1
referring to:
Ibandronate
The information in this safety data sheet is based on current scientific knowledge. It should not be
taken as expressing or implying any warranty concerning product characteristics.
Date: 2.7.15/LS (SEISMO)
Replacing edition of:
19.6.14
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